Non Interventional Clinical Investigation of Ectoin Ear S... | NCT02558738

Studies
Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations

NCT02558738

Sponsor

Bitop AG

Status

Completed

Last Update Posted

Jan 30, 2026Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Pruritus
Dermatitis
Otitis Externa

Interventions

ear spray

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2015Actual

Primary Completion Date

Aug 14, 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 14, 2015

First Submission Date that Met QC Criteria

Sep 23, 2015

First Posted Date

Sep 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ectoin Ear Spray		treatment according to instruction for use	Device: ear spray
Normison ear spray		treatment according to instruction for use	Device: ear spray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ear spray	Device		Ectoin Ear Spray Normison ear spray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pruritus at outer ear canal	assessment of the symptoms on visual analogous scale	14 days

Secondary Outcomes

Measure	Description	Time Frame
Severity of pruritus	assessment of the symptom on Visual Analog Score on values between 0 and 10	14 days
Dermatitis	assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

according to instructions for use

Exclusion Criteria:

otitis media, acute otitis media
acute otitis externa
earache
perforation of the ear-drum (membrana tympani)
infections at the ear
systemic corticosteroid treatment or local at the ear

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care ENT units study the therapeutic process in this observational trial in total of 60 patients in three centres with dermatological irritations of the outer ear canal and pruritus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Uwe Sonnemann, Dr med	HNO Praxis Elmshorn	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HNO Praxis Elmshorn		Elmshorn			Germany
HNO Moeller

Condition Browse Module

MeSH Terms

ID	Term
D011537	Pruritus
D003872	Dermatitis
D010032	Otitis Externa

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided